Projects

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

50.60 Close of voting. Proof returned by secretariat

Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility

50.60 Close of voting. Proof returned by secretariat

Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

50.60 Close of voting. Proof returned by secretariat

Antimicrobial wound dressings - Requirements and test method

50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks

Medical vehicles and their equipment - Road ambulances

50.60 Close of voting. Proof returned by secretariat

Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin

50.60 Close of voting. Proof returned by secretariat

Sterilization - Steam sterilizers - Large sterilizers

50.60 Close of voting. Proof returned by secretariat

Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)

50.60 Close of voting. Proof returned by secretariat

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

50.60 Close of voting. Proof returned by secretariat

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/FDIS 10993-17:2023)

50.60 Close of voting. Proof returned by secretariat

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

50.60 Close of voting. Proof returned by secretariat

Aseptic processing of health care products - Part 1: General requirements (ISO/FDIS 13408-1:2023)

50.60 Close of voting. Proof returned by secretariat

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)

50.60 Close of voting. Proof returned by secretariat

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)

50.60 Close of voting. Proof returned by secretariat

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022)

50.60 Close of voting. Proof returned by secretariat

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)

50.60 Close of voting. Proof returned by secretariat

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)

50.60 Close of voting. Proof returned by secretariat

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks